Release Date: September 12, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Innate Pharma SA (IPHA, Financial) has a strong pipeline of differentiated antibodies, including lacutamab, ANKET, and ADCs, which are progressing through various clinical stages.
- The company has secured key partnerships with industry leaders such as AstraZeneca, Sanofi, and Takeda, enhancing its development capabilities and market reach.
- Lacutamab has shown promising results in treating cutaneous T-cell lymphoma (CTCL) and has received orphan drug designation from the FDA, potentially expediting its approval process.
- The ANKET platform, particularly the tetra-specific antibody IPH65, has entered clinical trials and shows potential for treating relapsed and refractory B-cell non-Hodgkin's lymphoma.
- Innate Pharma SA (IPHA) has a solid financial position with $102.1 million in cash and equivalents, sufficient to fund operations until the end of 2025.
Negative Points
- The company is currently operating with an interim CEO, which may impact strategic decision-making and long-term planning.
- Revenue for the first half of 2024 was relatively low at $12.3 million, indicating a heavy reliance on future product approvals and partnerships for financial growth.
- Operating expenses remain high at $38.7 million for the first half of 2024, with a significant portion allocated to R&D, which could strain financial resources if revenue does not increase.
- The termination of the early-stage deal with Takeda may indicate challenges in maintaining long-term partnerships and could impact the development of certain ADC programs.
- Regulatory interactions and approvals for key assets like lacutamab are still pending, creating uncertainty around the timeline for market entry and revenue generation.
Q & A Highlights
Q: On the NeoCOAST-2 data for lung cancer, how does monalizumab's efficacy compare to Dato-DXd, and what is its potential role in this setting?
A: Yannis Morel, Chief Operating Officer: The NeoCOAST-2 data are encouraging for monalizumab, showing superiority in PCR and NPR rates compared to known agents. The study is run by AstraZeneca, and we look forward to seeing the final data. The main message is that monalizumab reinforces confidence in its activity in early lung cancer.
Q: Can you provide an update on the CEO appointment and how strategic decisions are being made in the interim?
A: Herve Brailly, Interim Chief Executive Officer: The CEO recruitment process is ongoing, and we should be able to update the market soon. Strategic decisions, such as those regarding lacutamab, are being prepared and will be made by the Board with the new CEO in place.
Q: What details can you share about the interim analysis for PACIFIC 9 and the timing of the next steps?
A: Yannis Morel, Chief Operating Officer: We cannot provide more details than what has been shared. The IDMC reviewed the data and recommended the trial continue. Regarding timing, the original PACIFIC trial took about three years from the first patient to the final analysis. We expect regulatory interactions for lacutamab in the fourth quarter of this year.
Q: What are the expectations for the CD20 ANKET asset in early development, and what types of patients are being enrolled?
A: Sonia Quaratino, Chief Medical Officer: We are in dose escalation and expect to complete this phase next year. We are looking for safety profiles, pharmacodynamic markers, and preliminary antitumor activity. The trial is enrolling non-Hodgkin lymphoma patients, mainly DLBCL, but is open to other CD20 positive subtypes.
Q: Can you provide an update on the progress and expected data for the KILT trial in PTCL?
A: Sonia Quaratino, Chief Medical Officer: The KILT trial, sponsored by the Lisa Group, is ongoing and recruiting. The study is on track for completion by late next year.
Q: What is the development plan for the Nectin-4 ADC, and will it include patients pretreated with Padcev?
A: Sonia Quaratino, Chief Medical Officer: The Phase 1 trial for the Nectin-4 ADC will start by the end of the year, focusing on indications with moderate Nectin-4 expression, such as bladder, breast, non-small cell lung cancer, and esophageal tumors. Pretreatment with Padcev is not an exclusion criterion.
Q: What are the next steps for lacutamab, and are there any partnership opportunities being considered?
A: Sonia Quaratino, Chief Medical Officer: We are engaged with the FDA on a proposed registration strategy for fast-to-market approval. We are also exploring different options, including partnerships, for the development of lacutamab in CTCL.
Q: What impact does the termination of the Takeda partnership have on your ADC program?
A: Yannis Morel, Chief Operating Officer: The termination was due to a strategic review by Takeda and does not impact our ADC program. The partnership was at a very early stage, and there is no significant data generated that affects our development.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
